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NCT Number: NCT02713295

A Study to Provide Real-world Evidence on the Treatment Goal Achievement Rate, Adherence to and Utilization Patterns of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in Greece

This study estimates the treatment goal achievement rate, depicts the implementation of the Progressive Psoriasis Initiative (PPI) recommendations regarding treatment modifications and transitioning, and assesses patient adherence and persistence with adalimumab therapy in the routine clinical practice in Greece.

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Key information

Conditions

Moderate to Severe Plaque Psoriasis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Univ Hosp "Attikon" /ID# 149517, Athens, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of plaque psoriasis for at least 6 months, and moderate to severe disease course at the time of adalimumab treatment onset, defined as Body Surface Area (BSA) >10 or PASI >10 and DLQI >10
  • Patients for whom the decision to prescribe therapy with adalimumab (Humira®) according to the locally approved summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study
  • Patients with an available Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores at the start of adalimumab treatment
  • Patients able and willing to provide written informed consent and to comply with the requirements of this study protocol
  • Patients with a signed informed consent document

Exclusion criteria

  • Patients should not have non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular)
  • Patients for whom treatment with adalimumab has been initiated more than 2 weeks prior to their enrolment into the study
  • Patients that meet any of the contraindications to the administration of the study drug according to the latest version of the locally approved SmPC
  • Patients who have previously been exposed to adalimumab unless a period of at least 6 months from the last dose has elapsed
  • Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with adalimumab.

Treatment and study plan

Primary outcomes

  1. Proportion of participants who will achieve the European Consensus Programme (ECP)-defined treatment goals at the end of the induction phase (i.e. 16 weeks post-treatment onset)

    Time frame: 16 weeks post-treatment

    Achievement of the treatment goals during the induction phase is defined as:

    • Treatment Success: i.e. >=75% Psoriasis Area Severity Index (PASI) score reduction OR
    • Intermediate Response with Dermatology Life Quality Index (DLQI) <=5: i.e. PASI score reduction >=50% but <75% with DLQI <=5.

Secondary outcomes

  1. Proportion of participants achieving intermediate response

    Time frame: Up to 12 months

    Intermediate response is defined as participants with PASI score reduction >=50% but <75% compared to week 0 (baseline).

  2. Proportion of participant achieving treatment success

    Time frame: Up to 12 months

    Treatment success rate is defined as participants with >=75% PASI score reduction compared to week 0 (baseline).

  3. Proportion of participant with treatment failure

    Time frame: Up to 12 months

    Treatment failure is defined as participants with PASI score reduction <50% compared to week 0 (baseline).

  4. Proportion of participants achieving the treatment goals

    Time frame: Up to 12 months

    According to the European Consensus Programme (ECP) guidelines, achievement of the treatment goals during the maintenance phase is defined as:

    • Treatment Success: i.e. >=75% Psoriasis Area Severity Index (PASI) score reduction compared to the time of therapy initiation (i.e. baseline) (or)
    • Intermediate Response with Dermatology Life Quality Index (DLQI) <=5: i.e. PASI score reduction >=50% but <75% compared to baseline, with DLQI <=5.

  5. Time to the first missed dose during the study observation period

    Time frame: Up to 12 months

    Patient diary will be reviewed to assess this information

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Non-interventional Prospective Cohort Study to Provide Real-world Evidence on the Treatment Goal Achievement Rate, Adherence to and Utilization Patterns of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in Greece

Acronym: CONCORDIA

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2016
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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